Gardasil Archives - Page 5 of 6

Gardasil Injured

Published on July 15, 2013

7496 views

I am the mother of my precious little girl Alisa (pictured). Though she is not little anymore, she will always be my princess. Alisa grew up healthy, active, and happy. She enjoyed trying new things and being around others. She loved photography, fishing, bike riding, boating, hiking, martial arts, music (especially her violin), and all types of animals. In high school she enjoyed her photography in which she won awards for. She was a tattoo assistant for a Washington State award winning tattoo artist and was learning the trade. She was on the swim team and loved swimming. Being a concerned mother I was fearful for her getting cervical cancer. We were being bombarded with commercials and ads for this vaccine for girls to be one less. When they offered the vaccine to my daughter I said sure. They never went over side effects or problems, so I figured it was a safe one. That day is when our nightmare began.

August 14, 2007, the first vaccine shot ( lot # 0384U) – Alisa went home with her injection site itchy, swollen, red, and sore. She was not feeling well, like flu. I sent her to bed and she was home sick for a couple days. The doctors office said that was normal. I did notice she was complaining about sore joints and muscles in the months to follow and she was napping more with headaches. I just blamed it on growing pains.

November 14, 2007, second vaccine shot (lot # 0927U) – Alisa was not thrilled about having the shot again. She was so scared she was going to feel crummy again. Sure enough the injection site was itchy, sore, red and this time the area swelled up a large area. She went home and went to bed. She was out of school again down with flu like symptoms for days. Slowly she came out of her slump but was so sore throughout her body. Sore muscles and joints, complained of headaches. She was exhausted all the time. It was difficult for her to muster the strength to do things. She took to her computer and was playing games online with friends.

Happy Valentines Day to you….February 14, 2008 (lot# 12APR10). This time she was flat terrified and cried all the way to the doctors begging me not to make her get the vaccine. This breaks my heart because I remember this day too vividly. I kept telling her it was the last shot and we don’t want to make the other two shots go without the final one. I kept telling her it was for the best. We left the office and she was throwing up, shaking, feverish, and the usual symptoms of sore muscles and joints, a pounding headache, exhaustion. She was down for over a week recouping from the shot.

After the 3 shots I put the series out of my mind. The only time that I remember the shots was EVERY visit to the hospitals and Dr.s offices, when they would ask if Alisa had all her vaccines. EVERY time I answered I said, “yes she has even had the Gardasil series.” Not one doctor put this together. The cause to her illnesses were put together by good friends of the family.

Many of you may wonder why I continued taking her in for the vaccine series. I called the doctor’s office about her reactions each time, and they said it was completely normal to have those “minor” reactions: swelling, itching, light headed, and dizzy. After all it is a shot!!!! They also said at the doctor’s office, NO ONE has ever had the flu like symptoms from the vaccine, so she must have a touch of the flu. When the third dose came around they stressed to us that the other two shots of the vaccine would have been useless without the third. I trusted our family doctor of 15 years. He had never steered us wrong and always took care of us – treated us honestly and fair. I grew up with my grandfather being a doctor and most of my aunts being RN’s, I worked in the medical community. I trusted them….It never dawned on me they could be wrong.

Alisa continued on with her life but lost some of her spunkiness. She no longer had tons of energy. She slept a bunch, stopped her swim team, and spent more time in her room on the computer. She said her body hurt and didn’t feel like doing anything.

There are so many doctors appointments and hospital visits in this time frame. I have requested all her records from the hospitals, clinics, and her primary care provider (he has discharged her from his office).

October 2009, another visit to the emergency department with eye problems. She was having bloody discharge and pressure behind her right eye. Alisa was having problems with slurred speech, headache and facial droop. They accounted it to pink eye and we begin treatment. They recommend we contact a neurologist and see the doctor.

After seeing the neurologist finally we were sent home with the idea of further testing later. Later that night the neurologist called recommending we take her back to the hospital for further testing. October 2009, off to the hospital again. By this time, Alisa was admitted into children’s hospital with the following symptoms: Bells Palsy, migraine, right sided weakness, blurry vision, tinnitus, balance problems, numbness right side, unable to walk, problems swallowing, fatigue, joint pain, difficulty in opening mouth. They were testing for stroke and other unknown causes to this problem. She endured CAT scans, MRI’s, Lumbar punches. Over the next week she continued to get worse. Of course the psychiatric doctors were sent in to ensure she wasn’t an abuse victim. We didn’t know yet then she was abused by the pharmaceutical company. She was discharged without a cause to the problem.

This was Alisa’s senior year in high school, though the first semester she was in the hospital and a tutor came in a few times a week to drop off and pick up homework. The doctors released her to return to school but the noises, medications, and lights caused her headaches to pound and she was struggling with anxiety issues. With only one semester until graduation she dropped out of school. It was too much to handle. (She tested and passed her GED in Dec. 2011).

Over the following years Alisa has had this happen 2 more times. Right side paralysis, wheelchair, learn to walk with a walker again, and now she gets so exhausted she uses the wheelchair to save her energy.

Her side effects seem to increase in intensity and keep adding in numbers. So far she struggles with the following issues: leaky gut syndrome, pins and needles in extremities, dizziness, bleeding gums, toothaches/teeth changes, brain fog, sensitivity to chemicals, chest pains, constipation, dehydration, enlarged liver, sound sensitivity w/anxiety, extreme pain in the tailbone area, fainting, fever and blisters, fibromyalgia, Guillain-Barre syndrome, autistic-like symptoms, hand/leg weakness, back pain, hot//cold intolerance, trouble sleeping, itching, joint pain, knee pain, light sensitivity, blindness, depression, personality changes, anxiety/panic attacks, loss of bladder control, bladder issues, muscle aches and spasms, muscle tension, tumor, paleness, chronic fatigue syndrome, paralysis, pneumonia, severe nerve pain, shortness of breath, slurred speech, smell sensitivity, diarrhea, sore throat, stomach pain, swelling/edema, tremors hand and/or leg, random twitching of extremities, bloating, uterine spasms, hair loss, urinary tract infections (UTI), kidney issues, vision loss (temporary/permanent), vision problems, dyslexia, hallucinations, vomiting blood, stomach ache, nausea, rashes, appetite loss, weight gain or loss ( 20-30lbs).

Alisa is unable to anything without supervision. Showering requires a shower chair. She has to be checked on constantly since her seizures come without notice. She becomes so disoriented after some of the seizures, she wanders off.

Alisa was once firm in her beliefs about anti-smoking and drug use, but has now become a medical marijuana patient. This is the only thing that takes an edge off the pain. She is never pain free but the MMJ makes it more tolerable. Unfortunately this pain relief isn’t covered by medical insurance so the $1200.00 a month pain control comes out of the pocket book.

This vaccine has dramatically changed our family’s life. Alisa fights for her life everyday. It is even more difficult to not be able to help her or find a cure for her symptoms. It is heartbreaking to watch your child suffer in horrible pain and not be able to help. I feel guilty because my child is suffering because of a choice I made. A choice I thought was to help her and instead has disabled her. I wish someone would have told me. Please help spread the word about this vaccine. Tell everyone you know about the dangers of the vaccine. Educate before you vaccinate. This vaccine is harming thousands of girls, and now boys. The vaccine needs to be taken off the market. The numbers of children affected is rising everyday.

Participate in Research

Hormones Matter^TM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey.

To take one of our other Real Women. Real Data.^TM surveys, click here.

To sign up for our newsletter and receive weekly updates on the latest research news, click here.

Rolling the Dice with the HPV Vaccine

by Tracie Moorman

Published on June 6, 2013

3473 views

If you are the parent of a minor child, you most likely have heard about one or both of the HPV (human papillomavirus) vaccines currently on the market. A trip to the pediatrician’s office with a teen or pre-teen is typically where the first discussion takes place. The doctor will dutifully recite information. HPV is the most common sexually transmitted virus in the United States. As a parent, that gets your attention. They go on to further state that the vaccine will protect your child from the strains of the virus that most commonly cause cervical cancer in females and genital warts in males. These are both very uncomfortable subjects for most of us. However, as parents, we want to protect our children at all costs from anything and everything possible.

As with any vaccine, the parent is provided a pamphlet or sheet containing the standard information: what is HPV, why get vaccinated, who should get vaccinated, and the obligatory safety information. After reading the information and listening to the doctor’s recommendation explaining that the vaccine is very safe (and it seems to be for most patients), many parents make the decision to have their child protected. I was one of them. I rolled the dice and sadly, my daughter lost.

The information pamphlet states that the vaccine has been used in the United States for about six years and has been very safe. You are warned about pain and swelling of the injection site, fever, headache, and the most troublesome side effect, fainting. The patient is required to remain in the doctor’s office for a period of time after the injection as a safety precaution.

What the information pamphlet does not address is that over 29,300 injuries and 136 deaths have been reported following HPV vaccines. Vaccine injury reporting is voluntary in our country and the Center for Disease Control acknowledges that adverse events, as they are called, may be 10 to 100 times greater than those actually reported. Do the math. The reported numbers seem very significant to me, but I am the mother of one of the injured. I trust we can all agree that the actual numbers could be staggering.

The list of new medical conditions being reported following the HPV vaccine is also staggering, I counted 144 conditions. My daughter has 31 of them. She suffers mainly from neurological, autoimmune, and adrenal issues. The worst offender is a migraine-like headache that has been present every day, all day and night for more than a year. The neurologist refers to it as migraine-like because all the symptoms are there yet it does not respond to any medication. Her immune system has also been compromised. She suffers from leaky gut syndrome and now has sensitivity to 20 common foods. Dealing with this for more than a year now has taken a toll on her 16-year-old body. Chronic pain has lead to depression and adrenal fatigue. All of this in a girl who had what was described as an “unremarkable’ medical history prior to vaccination.

While my daughter’s symptoms are grave, she really is one of the lucky ones. Many of the injured suffer from daily seizures or even multiple seizures per day. My daughter does not. For that, I am thankful every day. Having a child in crisis is hard. Having a child with a medical crisis that medical doctors do not know how to reverse is even more difficult. My decision to protect her, in fact, caused her great harm.

Choosing to give your child a vaccination is a personal decision, but it is one that should not be taken lightly. Do your own research, do not simply rely on the information pamphlet, it is, after all, written by the vaccine manufacturer. I learned this lesson the hard way. When you decide if you will roll the dice, please, for the sake of your child, remember this: Education conquers fear and knowledge is power.

Gardasil Cervarix HPV Vaccine Research

Hormones Matter^TM is conducting a large scale assessment of symptoms and adverse reactions associated with the HPV vaccines, Gardasil and Cervarix. If you, your daughter, other family member or friend have had either of these vaccines, we encourage you to take this important survey. The data collected with help delineate the range, severity, frequency and onset of health symptoms associated with Gardasil and/or Cervarix. For more information or to take the survey: The Gardasil Cervarix HPV Vaccine Survey.

Gardasil Autopsies Reveal Cerebral Vasculitis

by Chandler Marrs, PhD

Published on June 5, 2013

7179 views

Controversy about Gardasil and Cervarix related injuries surrounds the HPV vaccine. Almost to a tee, major medical centers, presumed thought leaders, post market surveillance, regulatory agencies and the press, promote the safety of these vaccines. It is incomprehensible to these organizations that such a perfect vaccine could cause serious injury or death. Any new report suggesting otherwise is quickly and summarily rejected, the families of the young women injured or killed are lambasted. Rarely, does anyone standup and support the injured, lest they too be considered among the fringe. All the while, girls and women and their families continue to be injured or even worse lose their lives, by what pro-industry PR suggests are unexplained reasons.

Well, explain them damn it. If it is not the vaccine, then what? Neither the post-vaccine reactions nor the deaths are random and though the culprits may be complicated, basic human decency, not to mention medical ethics demand that we make an effort to understand the causes of the adverse reactions so that we might prevent them.

Looking for Clues

A group of researchers from University of British Columbia are attempting to do just that – to understand the constellation of adverse reactions reported post vaccine. In one of their latest reports, published last fall in the open access journal Pharmaceutical Regulatory Affairs, they uncovered evidence of a deadly and difficult to diagnose condition called cerebral vasculitis.The syndrome fits clinically based on the presentation of symptoms reported. The study is not without problems and certainly not without criticism from industry. Here is a review and my thoughts on the research and the reactions to the study from industry and regulators.

What is Vasculitis?

Vasculitis is an autoimmune mediated attack within the walls of the blood vessels, that weaken and sometimes necrotize or kill the vessel. The central feature of vasculitis is the inflammatory destruction of the blood vessel. Vasculitides, as they are called, can develop anywhere in the body, in large or small vessels. Where the vasculitides develop and the size and type of vessels involved determines the types of symptoms that present and how the functioning of the injured physiological system will be affected. As a result, the symptoms often appear heterogeneous and non-specific, making vasculitis very difficult to diagnose – unless one was looking for it. This report suggests that we ought to begin looking for it.

Peripheral and Cerebral Vasculitis

When vasculitis occurs in the body – peripheral or systemic vasculitis, symptoms include but are not limited to:

distinct skin rashes (click link to see image)
excessive fatigue (tiredness)
weakness
fever
joint pains
abdominal (stomach) pain
gastroparesis
kidney problems (including dark or bloody urine)
Graves’ Disease or Hashimoto’s thyroiditis

When vasculitis develops in the central nervous system – the brain and the spinal cord, symptoms include but are note limited to:

nerve problems (including numbness, muscle weakness, and pain)
severe headaches that last a very long time
strokes or transient ischemic attacks (“mini-strokes”)
forgetfulness or confusion
delirium and/or depressed consciousness
problems with eyesight (likely problems with hearing, but no cases cited)
speech problems
emotional regulation problems
seizures or convulsions
encephalopathy (swelling of the brain)
sensation abnormalities

Cerebral vasculitis, also called autoimmune encephalitis, represents one of the rarest forms of vasculitis because it requires the toxin or mediator to cross the blood brain barrier. Current estimates suggest an annual incidence of only 1-2 cases of cerebral vasculitis per million adults. Cerebral vasculitis is also the most deadly, as the immune system mediated attack of the small to medium blood vessels in the brain often leads hemorrhagic or ischemic stroke and can lead to death.

Gardasil Autopsy Reports

The current study, Death after Quadravalent Human Papillomavirus (HPV) Vaccination: Causal or Coincindental? examined the brain tissue of two young women who died suddenly after receiving the HPV vaccine, Gardasil. One of the young women was 19, healthy, medication free and had no previous medical history. She died in her sleep after being given the third dose of the vaccine, which elicited an apparent exacerbation of symptoms that had developed soon after the first dose.The symptoms that emerged after her first dose included: warts on her hands, fatigue, muscle weakness, tachycardia, chest pain, tingling in her extremities, irritability, confusion and memory lapses or amnesia.

The other young woman was 14 years old, had a history of migraines and was using oral contraceptives. Within two weeks of her first dose, she developed a constellation of symptoms that included exacerbation of migraines, speech problems, dizziness, weakness, inability to walk, excessive vomiting, depressed consciousness, confusion, amnesia. Two weeks after the second dose, she was found dead in the bathtub by her parents.

The original autopsies for each the young women revealed no abnormalities and no precise cause of death. With the second girl, the coroner noted cerebral edema and what is called cerebellar herniation – a condition where brain swelling pushes against lower brainstem compressing the region responsible for respiration (breathing) and heart function. Even though histopathology was done as part of the autopsy, the coroner’s reports provided no indication of which antibodies were used for histology investigations, suggesting only general and non-specific histopathology, making it near impossible to determine if the HPV vaccine was in involved.

Advanced Immunohistochemistry

Without the appropriate immunohistochemical (IHC) examinations, using specific antibodies to tag the antigens used in the HPV vaccine, there was no way for the coroner to determine whether the HPV vaccine elicited or contributed to the deaths of these girls. Knowing this, the current researchers developed a specific IHC to examine the brain tissue and determine whether the vaccine was responsible. What they found was disturbing, but incredibly important.

The IHC from this study found evidence of autoimmune cerebral vasculitis triggered by the HPV16L1 component of the vaccine. HPV16L1particles were identified all over the cerebral vasculature including adhering to the vessel walls. They also observed an increased expression of the complement of immune markers consistent with vasculopathic syndromes. These included:

Excessive adhesion of T lymphocytes
MHC- II signaling and deposition of immunoglobulin G-immune complexes to cerebral vasculature
Increased MMP
Intense micro- and astrogliosis

Diagnosing Vasculitis

Diagnosing vasculitis is difficult both because of its rarity, especially in young, previously healthy, individuals and because the constellation of symptoms often mimic other conditions. Blood work, angiography and often a biopsy of the tissue in question are required but not always confirmatory, making this diagnosis as much about clinical expertise as testing.

Once diagnosed, the treatments include, high-dose corticosteroids and sometimes, chemotherapeutic agents. If diagnosed, it can be treated or at least maintained. The problem, is that currently few physicians are looking at vasculitis as a possible culprit for the range of symptoms exhibited by Gardasil or Cervarix injured young women. This study suggests we should. There are however, dissenting opinions.

Dissenting Opinions and Possible Problems with the Findings

Following the publication of these findings in October 2012, the CDC convened a panel in November 2012 to review the report. The CDC panel identified concerns with the study methods and interpretation of findings. The working group contends that:

A finding of vasculitis requires evidence of inflammatory infiltrate damage within the vessel wall and that standard histopathology testing (hematoxylin and eosin- H&E stain) stain would have identified said damage. Since the H&E stain was negative, vasculitis was not evident and did not exist.
Details of the authors’ histopathology methods/staining and the appropriate control data (HPV vaccine free brain tissue) were not included, are new, have not been tested and therefore, are not valid.
HPV-16L1 particles are too small to identify using light microscopy, electron microscopy (EM) would have been required. The authors provided no evidence that EM was used. And again, the issue of the lack of control specimen was indicated as a flaw.
Lack of information about alternative causes of death.

Rebuttal of CDC Panel Findings

Comparing apples to oranges. Neither of the two studies the CDC offers as evidence against the finding of cerebral vasculitis involves research on cerebral vasculitis. One of studies cited is a letter to the editor published in the Rheumatology journal reporting two cases of skin vasculitis, post-Gardasil vaccine; evidence that appears to support a linkage between the HPV vaccine and vasculitis in general rather than dismiss it.

The second study cited as evidence against cerebral vasculitis was the CDS’s own study, a 2009 Post Liscensure Gardasil Surveillance Report that reviewed and tabulated the Vaccine Adverse Event Reports (VAERs) data from June 2006, through December 2008. Neither cerebral vaculitis nor other forms of vasculitis was an endpoint or outcome variable evaluated in this study. Using the CDC’s Surveillance report, which neither included the very endpoints in question, nor gathered manufacturer independent data to verify claims to negate the findings cerebral vasculitis, is spurious at best, and disingenuous or worse when one considers the potential risks involved for getting this diagnosis wrong.

Technical and methodological criticisms. The technical criticisms against the cerebral vasculitis findings involve utilizing new, less well understood methods to detect the disease process versus accepted and tools and techniques. Only time and additional testing will tell whether these concerns are valid. This was a preliminary study, to reject it based on its newness and novelty, particularly when the risks are so high, seems unwarranted. Instead, additional research should be undertaken immediately to confirm or reject the claims and to validate or invalidate the methods.

No control data. This is a red herring, used against some studies when necessary and dismissed in others when it suits the critic. Other highly praised Gardasil studies, for example, find it perfectly acceptable to have no controls groups. Certainly, a control group would be ideal, but in preliminary case reports it is not necessary. The authors of the study in question address the lack of control subjects and recognize the need for additional research. It should be noted, however, that postmortem brain tissue analysis in young, healthy women is not common and it would be difficult to determine what was ‘normal’ versus abnormal. Again, rather than reject the findings of cerebral vasculitis outright, additional testing should begin to validate or invalidate these findings.

Is Cerebral Vasculitis or Vasculitis Linked to the HPV Vaccines?

At this point it is not clear, additional research is needed. However, the clinical presentation of adverse reactions appears to support cerebral and other regional vasculitides. Together with this preliminary postmortem tissue evidence, not only does the vasculitis linkage warrant additional investigation, I feel it should it be included in the diagnostic differential, particularly for the treatment refractory constellation of neurological and autoimmune symptoms so commonly reported by vaccine recipients.

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The Gardasil Cervarix HPV Vaccine Survey

by Chandler Marrs, PhD

Published on May 10, 2013

8588 views

Introducing the third in our series of Real Women. Real Data.^TM surveys: The Gardasil Cervarix HPV Vaccine Survey.

At Hormones Matter^TM we have covered the Gardasil story many times. We have been struck by the depth and breadth of adverse events experienced by young girls and women who have been given the HPV vaccines. We are concerned by the lack non-industry sponsored data regarding the range, frequency and severity of adverse events. We aim to solve that problem and we need your help.

About Gardasil and Cervarix

Individual reports abound about the dangers of the HPV vaccine, Gardasil. Less is known about Cervarix. Data collected from Vaccine Adverse Event Reporting System (VAERS) and reported on here, indicates a serious adverse event rate 4.3 per 100,000 doses of Gardasil. Serious adverse events are those that cause death or are life threatening, require hospitalization, cause persistent disability or incapacity and/or require medical treatment to prevent permanent impairment or damage. This is compared to a death rate of cervical cancer, which according to the WHO stands at 1.7 per 100,0000 cases in the US.

What we don’t know is who is most at risk for these adverse events. Are there particular pre-existing conditions, medications or even menstrual cycle triggers that increase the risk for an adverse event? What is the full range of side-effects and adverse events, short term and long term? Is either vaccine more risky than the other? These are questions that must be addressed so that as medical consumers we can make educated decisions about vaccine safety.

We need your help to gather these data. Please take this survey and share it with your friends, sisters, colleagues and anyone you know who has been given the HPV vaccine. Please post on your Facebook pages and share on Twitter, Linkedin, Reddit and other social media. We will need thousands of women to find the connections. That requires crowdsourcing and sharing amongst women.

Purpose the Gardasil – Cervarix Survey

Women and their physicians need more data about the side-effects of the HPV vaccines, Gardasil and Cervarix. There is a lack of data about who is at risk for adverse events and whether certain pre-existing conditions increase one’s risk for an adverse event. There is also a lack of data about the long term health effects of these vaccines. The purpose of this survey is to fill that data void; to learn more about the risks for and nature of adverse events associated with each of the HPV vaccines, Gardasil and Cervarix.

Who Should Take the Gardasil Cervarix HPV Vaccine Survey

Girls or women who have been given either vaccine or the parents or other family members of young girls given the vaccine.

We are not currently collecting data on the adverse reactions for men and boys, but intend to launch a separate survey to tackle that population.

How Long Does the Gardasil Cervarix HPV Vaccine Survey Take?

This is a long survey. We felt it was important to assess the full depth, breadth, onset and severity of adverse reactions in order to give parents and women the data they need to make informed medical decisions. This necessitated a longer than desired survey. We estimate it will take approximately 20-30 minutes to complete the survey. We hope, given what is at risk, survey respondents will take the time to complete the entire survey.

Is the Survey Anonymous and Secure?

Yes. We do not collect personal identifying information and the survey is hosted with SSL encryption using a verisign certificate Version 3, 128 bit encryption.

How Will the Data be Used?

To inform future research and women’s health decision-making.

Who is Conducting this Research?

Researchers from Lucine^TM, Hormones Matter^TM. For more information on Lucine, click here. For more information about Hormones Matter^TM , click here.

What Can I Do To Help?

Our organization is completely unfunded at this juncture and we rely entirely on crowdsourcing and volunteers to conduct the research and produce quality health education materials for the public. Get involved and help us prove that hormones matter and that women’s health data matter. Become an advocate, spread the word about our site, our research and our mission. Join our team. Write for us, partner with us, help us grow. For more information contact us at: info@hormonesmatter.com.

To take the Gardasil Cervarix HPV Vaccine Survey, click here.

To take one of our other Real Women. Real Data.^TM surveys, click here.

To sign up for our newsletter and receive weekly updates on the latest research news, click here.

Thank you in advance for your help.

Statistical Shenanigans with Gardasil Research

by Chandler Marrs, PhD

Published on May 8, 2013

3992 views

Something’s hinky in the land of Gardasil surveillance and it’s not just the vaccine. It’s the statistics used in one of their widely reported surveillance studies on Gardasil-suspected autoimmune conditions. From the medical marketing and even the abstract of the study, which is all that most will ever read, it looks like there is no connection between the vaccine and the onset of autoimmune conditions. Indeed, all of the major media reported the appropriate PR:

One organization even failed to change the url before directly copying the press release from another agency; (guess which one, I was surprised). It is unlikely that anyone read this study before blasting the PR far and wide. Otherwise, if they had read the dubious and creatively contorted statistical manipulations, the headlines would have been much different. Perhaps, Researchers Choose Statistics Least Likely to Find Results in Gardasil Study, would have been more appropriate.

I have a nasty habit of reading research before I write about it. I’m sure it will get me in trouble at some point, particularly as this blog grows, but I can’t help it. I want to understand the research. So here you go, my opinion and review on the Surveillance of Autoimmune Conditions Following Routine use of Quadrivalent Human Papillomarvirus Vaccine.

Gardasil and Autoimmune Conditions

Anecdotal evidence abounds suggesting that Gardasil is linked to an increased incidence of a wide array of autoimmune responses, but aside from the convoluted VAERs tabulations, very little in the way of actual data exist. In Merck’s FDA-mandated post market surveillance of Gardasil (which should have been pre-market testing if you ask me), the initial study conducted at Kaiser Permanente in California, purports no connection between 16 autoimmune conditions and the Gardasil vaccine. The conditions investigated included:

Immune thrombocytopenia
Autoimmune hemolytic anemia
Systemic lupus erythematosus
Rheumatoid arthritis
Juvenile rheumatoid arthritis
Type 1 diabetes
Hashimoto’s disease
Graves’ disease
Multiple sclerosis
Acute disseminated encephalomyelitis
Other demyelinating diseases of the central nervous system
Guillain-Barré syndrome
Optic neuritis
Uveitis

Though not a complete list, it’s a start and if that were the only flaw in the research, I wouldn’t be writing about this study, but alas, it is not. There are several hinky statistical maneuvers that make it all but impossible to draw any meaningful conclusions from this research.

Statistical Shenanigans

Hinky maneuver #1. The PR reports and the study abstract indicate that the study followed almost 190,000 women for 180 days after each vaccine dose. This would be a great study if it were true. It is not. Researchers reviewed a possible sample of 190,000 medical records (not actual girls and women, but their records, flawed as they may be) from girls and women who had received at least one dose of the Gardasil vaccine. They subsequently removed all records from patients who had not been Kaiser health plan members for at least a year, leaving 149,000. Still a large number of health records, but not the reported 190,000 girls and women followed post vaccine.

Hinky maneuver #2. From those records, they looked for possible new onset cases of the aforementioned diseases within what they defined as a risk period of up to 180 days post vaccine. Read beyond the abstract and we find that, not each dose received the same time frame. The risk period for the first dose was 60 days. This is problematic because a large percentage of patients chose not to receive all three doses and it often takes multiple months to receive a proper autoimmune disease diagnosis. Those data were not reported here and so, it is not clear how many cases may have been missed by essentially compressing the time of onset to within 60 days post first dose.

Hinky maneuver #3. From the 149,000 health plan members, 1014 potential new onset autoimmune cases were identified, 719 were deemed eligible for review (no definition of eligible was given) and only 347 were sampled for case review: “Because of the large number of potential new-onset cases identified for SLE (systemic lupus erythematosus, RA (rheumatoid arthritis ), JRA (juvenile rheumatoid arthritis), Hashimoto’s and Grave’s disease, a random sample of potential cases for these conditions was included for case review.” For the other conditions, which apparently didn’t have as high an incidence of new onset cases, all cases were included. Beyond the possibility of the admittedly ‘large number of potential new onset cases’ no reasons for reviewing only the sub-sample of the cases was provided, nor was an explanation of their ‘random’ sampling technique. What is clear though, is that by superficially limiting the number of cases, one skews the statistics and limits the ability to detect differences between the vaccine-related autoimmune and the non-vaccine autoimmune diseases.

Hinky maneuver #4 – the granddaddy of hinky maneuvers. Rather than do a matched case control study or a myriad of other possible, more logical and more powerful study designs to compare the rates or risks for onset of these conditions, this study (mis) used statistical techniques designed to manage missing data points (within a larger data sets), to effectively substitute a control group. There was no control group in this study. It was a statistical manipulation and a poor one at that, unless of course, the goal is to not find statistical differences, then it was a pretty creative choice.

Using a statistical procedure called Rubin’s multiple imputation, the researchers effectively (though not technically, for you stats wonks) estimated the data for the entire control group. According to the study authors, “by treating the actual status of new onset as missing data for the un-reviewed potential cases,” they imputed (substituted) 500 cases to come up with median, control group data that was then compared to the vaccine group data of 347 cases (the random sample of potential cases).

If this sounds really hinky, that’s because it is. By imputing the control group, they guaranteed that they would not find differences between the unvaccinated and vaccinated group. Indeed, they changed the question entirely. Their comparisons are no longer about the rates of onset between those vaccinated and those not vaccinated, but rather between those vaccinated verses those “estimated to potentially have a condition based on data imputation” which may or may not be the same as for those in the true unvaccinated population. This is completely different finding than what was reported in the study’s abstract, which is probably the sum total of what most PR and media companies read before regurgitating it endlessly through the news streams. And in that regard, this ‘study’ served the vaccine maker well, but it certainly does not serve the health of the public or scientific process at all.

Post Script. Poking through the statistical shenanigans, if we look only at the raw numbers from the abridged case pool, there appeared to be a high rate of Hashimoto’s, rheumatoid and other autoimmune conditions. However, without a properly designed study, it is difficult to delineate an expected incidence in the given population versus the observed incidence.

One Less After Gardasil

by Roxie Fiste

Published on May 2, 2013

21438 views

Imagine for a moment having an outgoing, vibrant daughter, just turned 21 years old – her whole life ahead of her. She’s a bright, outgoing, athletic, college student, kind and compassionate. She has hopes and dreams just waiting to be fulfilled. No parent could ask for more. All parental bias aside, this was our daughter, Brittney, before Gardasil.

When Brittney received her first Gardasil injection in June of 2007, she was told that the only real risk involved was the possibility of her having a small seizure shortly after the shot was administered. She did not react within the 15-minute window, during which the medical staff monitored her. She thought she had nothing to worry about. She admitted later, after she took the first dose, that the doctor had told her she could get the HPV viruses that cause cervical cancer through a lab accident at college, (where her blood might mingle with someone infected). She had been in a lab accident just a few months previous, so the fear of being infected was immense.

When she passed out the next morning on our family room floor, she got up wondering what had happened. Britt chalked it up to the possibility of being dehydrated. She had been quite active for several months. Several years before she had fainted from dehydration, so she didn’t think much of it. She was so unconcerned she didn’t even mention the incident until over a week later. By this point, she had experienced two other unusual episodes.

The next incident occurred nine days after her HPV vaccine injection. She had what we now know was a partial seizure. Three days later, her legs gave out while she was at a water park. Hammering pain spread up and down her legs for 15 minutes, then disappeared. As a parent, I was beginning to think the incidents were related, but was not sure how they were connected.

Britt is a fighter. She never backed down from anything, but charged head-on until she accomplished her goals. The nagging leg pain and the strange episodes of blacking out were just one more challenge to conquer. She pushed through summer determined nothing would prevent her from achieving her goal to graduate college and pursue a dream of becoming a singer/dancer.

Sometime mid-July, our doctor reassured us that what Brittney was experiencing had nothing to do with Gardasil. We were relieved – at least we could relax on that score…

In July, we took Britt to Myrtle Beach for a belated 21st birthday celebration. During this week, Brittney began to lose control of her emotions off and on. She would be completely normal, then suddenly explode. She would scream at us that we were trying to upset her, or prevent her from living her life. She had never acted this way in her life. Both my husband and I were shocked at her unprovoked outbursts. We spent the entire vacation walking on eggshells when she was present. It seemed the most innocent remark could set her off. The only thing that seemed to soothe her during that week was going to the ocean and walking the beaches.

In August, she had another ‘episode’ as the doctor called them, this time in the company of several college chums. One of them had a sister who experienced many seizures while growing up. She told Britt’s boyfriend at the time that it looked like Britt was having a partial seizure.

Unfortunately, the boyfriend would not accept this reality and shoved an inhaler in her mouth while she was unconscious and depressed it. Britt came around, choking on the aerosol. She told me about the incident later, which was upsetting. She also mentioned the incident to her doctor, but nothing more than a blood test was taken. The results showed that she was a little low on Potassium so she was told to eat more bananas.

In late August 2007, Britt received her second injection of Gardasil – again with no reaction during the 15 minutes of post-vaccination observation. But, within a week she began to have nagging issues with head pressure, like a cap with too tight of a band around her head. Over the next couple of weeks this progressed to the point where she could barely open her mouth because the muscles in her jaw were so tight. She began falling down for no reason. After three weeks, she began to experience blurred, doubled vision. She was extremely sensitive to light of any type. The pressure in her head was so intense, she was passing out daily. She developed a swelling that appeared to be filled with fluid at the base of her skull and along her spine. Along with all of the other symptoms, severe pain was raging through her body. As soon as her doctor examined the swelling, Britt was sent straight to the hospital.

Multiple tests were done, but nothing showed up on any of them. Britt was sent home with a couple of pain tablets. The resident on call felt she had some sort of brain virus and that it would go away in a couple of days.

From this point on, Brittney’s health deteriorated quickly. She couldn’t read anymore because the words seemed to run together or off the pages. She could no longer tolerate light or sound of any kind. We had to speak in whispers when near her or go up to the third floor and speak very softly. Her hearing was so sensitive that she could hear sirens more than three to four miles away and conversations several rooms away. She couldn’t sit in the same room with a television or radio on. Her pain was so bad, she cried all of the time. We bought noise cancelling headphones so she could tolerate trips to the doctor’s office. She had to have wrap around dark glasses – regular sunglasses were not sufficient to protect her from the severe sensitivity to light.

The nightmare didn’t stop there. Her face would sometimes droop to one side like it was sliding off her skull as pressure in her head grew worse. Seizures and stroking migraines began to happen 24/7. Her stomach was upset all the time. She could hardly keep anything down. She lost sensation in her legs and fingertips, she became completely bedridden, and simply longed to die.

Over the next three years, Britt was seen by over 60 doctors, including teams at Johns Hopkins Hospital, the Cleveland Clinic and the University Of Cincinnati Hospital. None of them could help her. She was so sick to her stomach, she could eat nothing but three ounces of protein drink at a time, fed with a baby spoon. Not one doctor suggested we have her stomach looked at. They simply dismissed it as being stressed, over-reacting to life, or a conversion disorder.

Just to give you an idea of what her new life is like, I will briefly touch on a few events:

January to March 2008 – Britt was totally bedridden and seemed to be wasting away. She nearly died before we found a doctor who helped alleviate some of her more severe issues. Unfortunately, she became intolerant of the medications that helped her. She began reacting to everything the doctor gave her. She was sent to many specialists who threw up their hands in frustration at her body’s resistance to treatments.
Early 2009 – We found an alternative chiropractor who recommended Okra Pepsin3 with Multizyme to help settle the lining of Britt’s gastro-intestinal tract. After several months, Britt was able to eat many organic and natural foods for the first time since her second Gardasil injection.
June 2009 – Brittney seemed to improve for a couple of months, including strength, but this didn’t last. By December she had lost all feeling in her legs, plus the head pressure had returned more intensely.
January 2010 – After being seen at Johns Hopkins Hospital Britt’s legs were put into massage bladders. This seemed to relieve some of the loss of feeling – when she left she could feel her upper thighs again. By spring, she was working with a researcher who was willing to try to help with some of Britt’s other issues. He suggested CoQ10, vitamin K Complex, magnesium, calcium and Vitamin D3 supplements. Britt’s sensitivity to light and sound diminished and some of her pain was alleviated. She had a boost of energy for the first time in three years.
April 2010 – A migraine specialist administered pain blocks to the back of her head (scalp) which relieved a great deal of the head pressure, jaw pain and complex migraines. She began to eat better.
June 2010 to January 2011 – Brittney seemed to be doing well. An alternative doctor had made some modifications to her diet that seemed to mitigate some of her more severe symptoms. She began a gluten-free, casein-free, sugar-free diet, avoiding Citric Acid, MSG, artificial preservatives, and mushrooms.
January 2011 – She was exposed to a virus. Her immune system could not handle it. She physically collapsed. The doctor told us that her immune system was crashing and he couldn’t help her. Britt’s grandmother sent over what we thought was homemade chicken with dumplings to boost her health. Brittney gained 60 pounds during the following 24 – 30 hours. We discovered there was Citric Acid in the broth. Nothing would bring the swelling down but time.
May to June 2011 – Her more severe pain symptoms calmed down a bit, but she was still vomiting. Her abdomen and stomach swelled to the point where she looked like she was six months pregnant.
2011 – We finally found a gastroenterologist who was willing to examine Britt’s stomach. She was horrified at what she found – Gastroparesis – a damaged Vagus nerve in Britt’s stomach which prevented normal digestion and emptying of her stomach.

Last summer, 2012, we started taking Britt to another alternative doctor. Gradually Britt began to have a small semblance of the life she had before Gardasil. After months of IV treatments, she has been able to handle a large crowd at a cinema, a very busy restaurant, and even go to the mall briefly. Understand that these events have taken place weeks apart. She still has a long way to go. She has been able to enjoy her favorite music with the speakers “normal” without suffering. She wears her wrap-around low vision glasses only on very bad days. She is able to walk on her own for short distances despite the lack of feeling in her legs.

January to April 2013 – Britt has had a huge setback which we believe was triggered by an LH hormone test. This test was to check the levels of these brain-based hormones to try to regulate them. She felt like the Gardasil nightmare was starting all over again before the hormone was neutralized. Within days of the test she began a slow increase of seizure activity, which built from a couple over a four month period, to multiple, daily events. Some were so severe that her power port shifted under her skin. After four weeks of non-stop seizures, we were able to get her in to the doctor’s office for a much needed IV. It took her nurse three tries to find, then flush the port, before the IV therapy could begin. Her seizure activity has now slowed to a minimum. As long as she stays on track for the IV’s, (basic vitamin/mineral infusions that help boost her immune system, calm physical issues, improve mal-absorption of nutrients), she can maintain much of her homebound activities. There are still periods when we talk with her that she displays signs of confusion, memory loss, and inability to concentrate.

Brittney has been ruled “Disabled” due to residuals of Gardasil by the SSA. She receives some compensation through the SSI which is helping pay her myriad medical bills.

Nearly six years ago, Gardasil changed our lives forever. It has been a nightmare without end watching our daughter suffer through every stage of the past several years. She has literally become ONE LESS!

Hormones Matter^TM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey.

To take one of our other Real Women. Real Data.^TM surveys, click here.

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Gardasil Research versus Marketing: The Reality of One Less

by Jordan Davidson

Published on March 11, 2013

3268 views

Back in 2006 when the Gardasil commercial first aired, the marketing mavens at Merck had us all humming along about how we wanted to be ‘one less.’ Now – 7 years and a myriad of articles, claims and additional research later, the question remains; what does it mean to be ‘one less’ and is it worth the price?

What is Gardasil? Gardasil is a vaccine approved by the FDA and recommended by the CDC as a preventative measure against four strains of HPV that are known to cause 70% of cervical cancer cases and 90% of genital warts. The vaccine must be administered over the course of a year via several injections. It is recommended for those who are not yet sexually active (i.e. younger girls, aged 9-12).

What is HPV and how is it related to Cervical Cancer? There are over 100 strains of HPV (Human papilloma virus) with approximately 30 of them being sexually transmitted. Research has found that, in rare cases, approximately 10 of those 30 strains can lead to cervical cancer. Most women are diagnosed with HPV via an abnormal Pap test. There is no cure for HPV and in most cases the infection goes away and the virus remains dormant within the body.

It is estimated that at least 20 million people in the US already have HPV; with about 50 percent of sexually active men and women at risk for acquiring a genital HPV infection during their lifetime. According to the CDC every year in the United States, about 10,000 women develop cervical cancer, and 3,700 die from it. Although cervical cancer is the second-leading cause of cancer deaths among women around the world, it ranks between 15th – 17th for cancer death in developed nations such as the US and Australia.

What do we know about the effectiveness of Gardasil? Unfortunately, the answer is not much. Despite information put forth by the US CDC, Health Canada, Australian TGA, and the UK MHRA, the efficacy of Gardasil in preventing cervical cancer has not been demonstrated. According to an article published in the Annals of Medicine, the longest follow-up data from phase II trials for Gardasil are on average 8 years. However, invasive cervical cancer takes up to 20 – 40 years after initial infection to develop into cervical cancer. Currently the death rate in the US from cervical cancer, according to World Health Organization (WHO) data (1.7/100,000), is 2.5 times lower than the rate of serious adverse reactions from Gardasil as reported by the Vaccine Adverse Event Reporting System (VAERS) (4.3 per 100,000 doses)

Since the vaccine is so new, and follow-up trials less than a decade old, the long-term health risks of Gardasil are still widely unknown. Adverse side effects have included death, convulsions, syncope, paraesthesia, paralysis, Guillain–Barré syndrome (GBS), transverse myelitis, facial palsy, chronic fatigue syndrome, anaphylaxis, autoimmune disorders, deep vein thrombosis, pulmonary embolisms, and pancreatitis.

Is it worth the cost? The vaccine only works against 4 HPV strains and annual pap screens are still needed to detect cervical cancer. The full injection sequence costs an approximate 400 USD, which is more than the cost of a pap screen. This nullifies any cost savings from the vaccine. In countries where cervical cancer deaths are the highest (Uganda, Nigeria, Ghana), the cost of Gardasil makes it an nonviable option. Current research suggests that by targeting other risk factors such as smoking, the use of oral contraceptives and chronic inflammation in conjunction with the already recommended and proven effective annual Pap test, global minimization of cervical cancer is likely – at equivalent or higher rates than those hypothesized for Gardasil.

For now, until more is known on the effectiveness and risks of Gardasil it may be better to be one more who goes for their annual exam and partakes in safe sexual practices than being an undetermined ‘one less.’

Hormones Matter^TM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey.

Gardasil and Thyroid Cancer: A Personal Account

by Danielle Nicosia

Published on January 17, 2013

7133 views

One reads about misdiagnoses in the medical world but no one truly talks of the frustration, relief and anger that follows after a patient finds out they have been misdiagnosed for years. I, for one, understand that feeling and everything that comes with it –this is my story.

I am 27 years old and have been sick for seven years. When I was 20 years-old I blamed my illness on the HPV Gardasil vaccine, which sent me to the hospital after two days of taking the shot. Following that incident, I was in and out of hospitals for years as they tried to find out what I had. The doctors were baffled and didn’t understand why I was having non-epileptic seizures; I experienced sensitivity to light, syncope, sudden loss of consciousness as many as 2 to 3 times an hour, followed by confusion, heart palpitations, extreme fatigue and pain and weakness in my legs. Although doctors did every test in the book, none of them knew what was wrong with me.

In 2008 I met with a neurologist at Winthrop University Hospital. He immediately admitted me for an MRI and CAT scan of my brain. After several weeks in the hospital the neurologist sent me to Long Island Jewish Hospital in New York, where I was admitted for two weeks for monitoring. After weeks spent in multiple hospitals, the doctors explained they couldn’t find the problem and had no concrete diagnosis. I was confused and frustrated; I knew there was something wrong.

The pain continued to increase; I felt pins and needles throughout my entire body and soon I couldn’t feel my feet or be able to stand. If I tried to stand for a few seconds, I would fall. I tried more doctors, but many of them didn’t feel comfortable treating me. Needless to say, I started to give up. I quickly went from walking perfectly fine, to needing a walker, and then being confined to a motorized wheelchair. In such a short amount of time for a young woman, this experience was horrifying. I couldn’t hold a job or go to college since the pain in my legs and feet was excruciating.

After more tests – EMG, CAT scans, MRI’s, and CTA’s – my lumbar puncture test showed I had fluid in my brain. How could this be I wondered.

In 2010 I went to a rheumatologist and he discovered that I had Fibromyalgia and Peripheral Neuropathy. To confirm the diagnosis several excruciating nerve tests were done. It turned out that this disease caused my immobility for many grueling months. The test results concluded I had nerve damage in my legs, which was preventing me to walk.

After years of tests, scans, blood work, and thousands of dollars in hospital bills, this rheumatologist finally understood my diagnosis. Unfortunately, the seizure-like symptoms were still occurring. My entire family and I were ready to give up in the summer of 2010, when I decided to go to Winthrop University Hospital in Mineola, New York to do Hyperbaric treatment. The doctors gave me Hyperbaric Oxygen Therapy, which was a life-changing therapy. The seizure activity lessened as the weeks passed and I finally returned to college. I was feeling better for the first time in many years.

In the summer of 2012 I began to have severe pain in my neck. At this time I didn’t have a regular physician so I found one and discussed my entire health history with him. The physician was extremely concerned so he sent me to see an oncologist right away. The oncologist reviewed my blood work and sent me to an endocrinologist because of the results. I waited several weeks to see the best chief endocrinologist in the area, when finally I felt some hope. I explained all my symptoms to the doctor including the pain in my neck, my weight gain, and my severe fatigue. He diagnosed me with Hypothyroidism. The doctor put me on a low dose of medication (Levothyroxine) and said, “see you in six months.” Hypothyroidism, I found out, is a thyroid disease in which your thyroid gland does not make enough of the thyroid hormone. Weeks later I found out not only did I have Hypothyroidism, I also have Hashimoto’s Thyroiditis which is an autoimmune disease that attacks your thyroid.

Weeks after this diagnosis, I began to have more pain in my neck and was starting to have problems swallowing food and water. At first I thought it was a cold coming on, but as weeks went by it didn’t subside. I returned to the endocrinologist and expressed my concerns but I was told that nothing was wrong and that I was suffering from a cold. I knew that I didn’t have a cold because I had just seen my regular physician who claimed I was healthy. The endocrinologist wouldn’t issue me a sonogram for my neck, so I called my oncologist who wrote me a script that same day.

In July 2012, I had a complete sonogram done of my neck at the Woman’s Breast Imaging Center located in Garden City, New York. That day turned into a four hour appointment, which was uncomfortable to say the least, especially since following my sonogram I had to be issued a biopsy. Hearing biopsy for the first time in my life was yet another horrifying experience. I remember sitting up on the examination table, crying as my cousin and mother tried to calm me down.

Several days later I received a call from the doctor in the imaging center. I knew right then and there, something had to be wrong. The doctor said my name, then paused. My heart skipped a beat as I waited for the news. “Danielle, you have Thyroid Cancer,” he said. “You need to be seen immediately at a cancer center to treat the two tumors in your body.” Tears streamed down my face. I couldn’t comprehend the words that were just said to me—I have cancer?

I realized then that the endocrinologist not only misdiagnosed me but didn’t pay attention to me when I was in pain. He brushed my symptoms and my concerns off as if I didn’t matter. Needless to say, I was livid.

Two days later I got a formal apology from the endocrinologist. I was shocked and impressed that he called. He apologized for misdiagnosing me and told me that if there was anything he could do to let him know. “I assume you do not want to come back to our office, but if you need anything I will be happy to help,” he said. I told him that the one thing he could learn from this is to listen to his patients. He took this advice with an embarrassed silence.

It took me four days to figure out where I should be treated. I was overwhelmed by the words, ‘you have cancer” and understood these three words would change my life completely. After thorough research, I decided to get treated at Memorial Sloan Kettering Cancer Center located in New York City. I had an amazing surgeon who did a total thyroidectomy and removed several lymph nodes that were cancerous. In December 2012, I started my treatment, which included Radioactive Iodine because of the spread. I had to be put in isolation for a few days because I was radioactive. While the experience was scary and unnerving, I owe a big thank you to my amazing surgeon and to my wonderful doctors at Memorial Sloan Kettering for saving my life. It was a relief knowing that my doctors had my best interest in mind.

Knowing something was wrong with my body when the world kept telling me otherwise was a lonely and frustrating–especially for seven years. Although the time was tough, it also taught me that I had to become an advocate for myself. Not only did the diagnosis of Papillary Carcinoma Thyroid Cancer change my life, but the journey itself did as well. I learned to trust my instincts, and that I am stronger mentally, physically and psychologically than I ever thought possible.

PLEASE GET YOUR NECK CHECKED!!

Below are resources that help those suffering of Thyroid Cancer:

1. Thyroid Cancer Survivors Association- http://thyca.org

2. Light of Life Foundation – http://www.checkyourneck.com

3. Follow Danielle’s Journey: http://findinghopewiththyca.blogspot.com

Hormones Matter^TM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey.

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